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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ultrasonic surgical
510(k) Number K211273
Device Name Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
Applicant
Ethicon Endo-Surgery, LLC
475 Calle C
Guaynabo,  PR  00969
Applicant Contact Nathan Anderson
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Road
Blue Ash,  OH  45242
Correspondent Contact Ruth James
Classification Product Code
LFL  
Date Received04/27/2021
Decision Date 05/21/2021
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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